Kentucky Department for Medicaid Services Drug Review and ...

Kentucky Department for Medicaid Services Drug Review and Options for Consideration

The following tables list the Agenda items as well as the Options for Consideration that are scheduled to be presented and reviewed at the November 19, 2020 meeting of the Pharmacy and Therapeutics Advisory Committee.

Single Agent Reviews

New Product to Market: Fintepla?

Options for Consideration

Non-prefer in the PDL class: Anticonvulsants: Second Generation (Anticonvulsants) Length of Authorization: 1 year Fintepla? (fenfluramine) indicated for the treatment of seizures associated

with Dravet syndrome in patients 2 years of age and older. Criteria for Approval Diagnosis of Dravet syndrome; AND Prescriber is, or has a consultative relationship with, a neurology/epilepsy

specialist; AND Trial and failure (e.g., incomplete seizure control) of 2 antiepileptic drugs;

AND Used in adjunct with 1 antiepileptic drug; AND Documentation (e.g., progress note or diagnostic report) or attestation that

echocardiogram assessments will be performed in accordance with the prescribing information. Renewal Criteria Documentation (e.g., progress note or diagnostic report) that echocardiogram assessments have been performed in accordance with the prescribing information; AND Documentation (e.g., progress note) of improved seizure control. Age Limit: 2 years Quantity Limit: 12 mL per day

? 2020 Magellan Health, Inc. All rights reserved. Magellan Medicaid Administration, part of the Magellan Rx Management division of Magellan Health, Inc.

Single Agent Reviews

Options for Consideration

New Product to Market: Non-prefer in the PDL class: Parkinson's Disease (Antiparkinson's Agents)

Ongentys?

Length of Authorization: 1 year

Ongentys? (opicapone) is a catechol-O-methyltransferase (COMT) inhibitor

indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease (PD) experiencing "off" episodes. Criteria for Approval: Diagnosis of Parkinson's disease (PD); AND Receiving PD therapy with carbidopa/levodopa; AND Experiencing "off" episodes with carbidopa/levodopa for at least 2 hours per day; AND Trial and failure of at least 2 adjunctive therapies, such as: o Dopamine agonists (e.g., pramipexole, ropinirole); o Monoamine oxidase-B inhibitors (e.g., selegiline) o Catechol-O-methyltransferase inhibitors (e.g., entacapone); AND NONE of the following contraindications: o Severe hepatic impairment (Child-Pugh C); OR o End-stage renal disease (creatinine clearance < 15 mL/min); OR o Use with a monoamine oxidase-B (MAO-B) inhibitor. Renewal Criteria: Patient has clinically meaningful response to treatment (e.g., patient shows a reduction in time of "off" episodes). Age Limit: > 18 years Quantity Limit: 1 per day

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Kentucky Department for Medicaid Services Drug Review and Options for Consideration

Single Agent Reviews

Options for Consideration

New Product to Market: Non-prefer in the PDL class: Immunomodulators (Cytokine and CAM Antagonists)

EnspryngTM

Length of Authorization: 1 year

EnspryngTM (satralizumab-mwge) is an interleukin-6 (IL-6) receptor antagonist

indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. Criteria for Approval:

Diagnosis of neuromyelitis optica spectrum disorder (NMOSD) confirmed by the following: o Seropositive for aquaporin-4 (AQP4) IgG antibodies; AND

o Presence of 1 core clinical characteristic (e.g., optic neuritis, acute myelitis, area postrema syndrome, acute brainstem syndrome, symptomatic narcolepsy or acute diencephalic clinical syndrome with NMOSD-typical diencephalic MRI lesions, symptomatic cerebral syndrome with NMOSD-typical brain lesions); AND

o Alternative diagnoses have been excluded (e.g., multiple sclerosis, sarcoidosis, cancer, chronic infection); AND

Patient meets ALL of the following conditions: o History of 1 relapse(s) that required rescue therapy within the prior year or 2 relapses that required rescue therapy within the prior 2 years; AND o Expanded Disability Status Score (EDSS) of 6.5 (e.g., requires 2 walking aids [pair of canes, crutches, etc.] to walk about 20 m without resting); AND

o At risk of having a disabling relapse of NMOSD for which oral agents (e.g., corticosteroids and immunosuppressants such as azathioprine and mycophenolate) alone are inadequate and biologic therapy is necessary; AND

o Screening for and absence of Hepatitis B, tuberculosis (TB), and other active infections prior to therapy initiation; AND

NOT previously treated with prolonged immunosuppressive therapy with alemtuzumab, cladribine, cyclophosphamide or mitoxantrone OR immunosuppressant procedures (e.g., bone marrow transplant, total lymphoid irradiation); AND

NOT to be used in combination with any of the following: o Multiple sclerosis agents (e.g., interferon, dimethyl fumarate, fingolimod, glatiramer, etc.) within 6 months of therapy initiation; AND o Other biologics used for the treatment of NMOSD (e.g., eculizumab, inebilizumab, rituximab).

Renewal Criteria:

Disease response as indicated by stabilization/improvement in any of the following: neurologic symptoms as evidenced by a decrease in acute relapses, stability, or improvement in EDSS, reduced hospitalizations, reduction/discontinuation in plasma exchange treatments, and/or reduction/discontinuation of corticosteroids without relapse.

Age Limit: > 18 years Quantity Limit: 1 syringe (1 dose) per 28 days; allow 2 syringes (2 doses) for the first 28 days

Kentucky Department for Medicaid Services Drug Review and Options for Consideration

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Single Agent Reviews

Options for Consideration

New Product to Market: Non-prefer in the PDL class: Antiretrovirals: HIV/AIDS (HIV/AIDS)

Rukobia?

Length of Authorization: 1 year

Rukobia? (fostamsavir) is a human immunodeficiency virus type 1 (HIV-1)

gp120-directed attachment inhibitor indicated for use in combination with other antiretrovirals for the treatment of HIV-1 infection in heavily treatmentexperienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations.

Criteria for Approval:

Diagnosis of human immunodeficiency virus (HIV); AND

Prescribed by, or in consultation with, an infectious disease specialist or HIV

specialist (AAHIVS); AND

Previous treatment with at least 3 drug classes (nucleoside reverse transcriptase

inhibitors [NRTI], non-nucleoside reverse transcriptase inhibitors [NNRTI], or protease inhibitor [PI]); AND

Documentation (e.g., progress note, lab report) of baseline viral load > 1,000

copies/mL on current antiretroviral regimen; AND

Used in combination with highly active antiretroviral therapy (HAART); AND NOT have impaired liver function.

Renewal Criteria:

Documentation (e.g., progress note, lab report) of a decrease in viral load from

pretreatment baseline. Age Limit: 18 years Quantity Limits: 2 per day

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Kentucky Department for Medicaid Services Drug Review and Options for Consideration

Single Agent Reviews

Options for Consideration

New Product to Market: Non-prefer in the PDL class: Multiple Sclerosis Agents

Kesimpta?

Length of Authorization: 1 year

Kesimpta? (ofatumumab) is a CD-20 antibody indicated for the treatment of

relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Criteria for Approval: Initially prescribed by a neurologist or multiple sclerosis specialist (non-specialist may renew and refill); AND Diagnosis of a relapsing form of multiple sclerosis (MS): relapsing-remitting MS (RRMS) active secondary progressive MS (SPMS), or clinically isolated syndrome (CIS); AND Inadequate response to, or unable to tolerate, 1 or more preferred MS agent; AND NOT have active Hepatitis B, or other clinically significant active infection; AND Baseline serum immunoglobulin measurement has been or will be performed; AND NOT used in combination with any other MS agent. Renewal Criteria: Documentation of response to therapy (e.g., progress note); AND Documentation (e.g., lab results) of ongoing serum immunoglobulin monitoring. Age Limit: > 18 years Quantity Limit: 0.4 mL (1 dose) per 28 days; allow 1.2 mL (3 doses) for the first 28 days

Kentucky Department for Medicaid Services Drug Review and Options for Consideration

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Single Agent Reviews

Options for Consideration

New Product to Market: Non-prefer in the PDL class: Spinal Muscular Atrophy

EvrysdiTM

Length of Authorization: 1 year

EvrysdiTM (risdiplam) is a survival of motor neuron 2 (SMN2) splicing modifier

indicated for the treatment of spinal muscular atrophy (SMA) in patients 2 months of age. Criteria for Approval: Infantile-onset (Type 1) Spinal Muscular Atrophy (SMA)

Member is 2 months of age; AND Prescribed by, or in consultation with, a pediatric neurologist or other specialist

in the diagnosis and treatment of spinal muscular atrophy (SMA); AND

Diagnosis of spinal muscular atrophy (SMA) Type 1; AND Genetic test results (i.e., laboratory results) confirming SMA:

o Homozygous deletion or mutation of the survival motor neuron 1 (SMN1) gene; OR

o Compound heterozygous mutation of the SMN1 gene; AND o At least two copies of the SMN2 gene. Patient does NOT require permanent ventilation (defined as requiring a tracheostomy or more than 21 consecutive days of either non-invasive ventilation ( 16 hours per day) or intubation, in the absence of an acute reversible event); AND

Prescriber conducts, and submits documentation of an assessment of baseline motor function using at least one of the following:

o Hammersmith Infant Neurologic Exam-Part 2 (HINE-2) o Hammersmith Functional Motor Scale Expanded (HFMSE) o Upper Limb Module (ULM) score o Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders

(CHOP-INTEND); AND

NOT to be used in combination with SpinrazaTM (nusinersen); AND

Patient has not received treatment with Zolgensma (onasemnogene abeparvovecxioi).

Later-onset SMA Prescribed by, or in consultation with, a neurologist or other specialist in the

diagnosis and treatment of spinal muscular atrophy (SMA); AND Member is 2 years of age; AND Diagnosis of spinal muscular atrophy (SMA) Type 2 or 3; AND Prescriber attestation/opinion that patient is non-ambulatory (e.g., requires

wheelchair, not able to walk unassisted, etc.); AND Documentation of baseline Motor Function Measure 32 (MFM32) score or

Revised Upper Limb Module (RULM) score; AND NOT to be used in combination with SpinrazaTM (nusinersen); AND Patient has not received treatment with Zolgensma (onasemnogene abeparvovec-

xioi).

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Kentucky Department for Medicaid Services Drug Review and Options for Consideration

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